^{*Analytical Reference Materials (ARMs) are released using a process developed by USP’s subject matter experts. The release process is based on internal policies, standard operating procedures, and requirements as defined by USP’s Quality Management System. USP is an ISO 9001:2015 certified facility. ARMs are different from official USP Reference Standards. ARMs are not required for compendial compliance.}

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FAQs

What is an excipient? 

Excipients are often referred to as “inactive ingredients” because, in drugs, they comprise everything except the active pharmaceutical ingredients (APIs). Excipient functions range from helping to guarantee the stability and bioavailability of the API to the drug product’s manufacturability to its texture and taste.

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What are high-risk excipients?

High-risk excipients are substances used in pharmaceutical formulations that pose a higher risk of contamination or adverse effects. These excipients require stringent control measures to ensure their quality, safety, and purity.

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What is a Monograph? 

A monograph is a written document that provides official standards for a drug substance or product. It contains detailed specifications including:

Description of the substance

• Identification tests
• Purity tests (e.g., limits for impurities)
• Assay methods (to determine content)
• Storage conditions
• Packaging requirements

 

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What is a Reference Standard? 

A reference standard is a highly purified compound that is used as a benchmark in testing. It’s typically a pure sample of the drug substance (or sometimes an impurity, degradation product, or metabolite) used in analytical procedures to calibrate instruments, validate methods, or compare results.

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What is a General Notice?

General notices are the official rules and definitions that apply to all monographs and general chapters in the USP–NF, unless stated otherwise. They explain how to interpret content, apply tests, and handle specifications across the compendium.

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What are General Chapters?

General chapters are sections in the USP–NF that provide standardized methods and guidance for testing, procedures, and practices used across multiple monographs.

• Chapters <1> to <999> are enforceable if referenced in a monograph.
• Chapters ≥<1000> are informational and offer best practices. They cover areas like microbiology, sterility, packaging, and analytical testing

 

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How does USP help with ensuring high-quality medicines and safeguard public health?

USP’s standards and solutions - monographs, reference standards, general chapters, DEG/EG toolkits, and other resources help ensure the quality of pharmaceutical products.

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Who can I contact to ask excipient-related questions? 

Talk to our experts and learn how our solutions can support your every need

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Is this relevant for pharma companies focusing on local markets?

Yes. For example, in India with Schedule M tightening, domestic manufacturers are now held to higher standards. Ensuring excipient quality isn’t just for exporters — it’s critical for passing inspections and maintaining product safety in India, too. Patient safety is universal.

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Do I have to be a large company to use USP?

Not at all. USP excipient standards are used by companies of all sizes — including MSMEs and CDMOs. They’re practical, affordable, and built to help smaller teams reduce risk without adding unnecessary complexity.

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What if my supplier says they’re compliant already?

Many suppliers say their material is pharma grade — but CoAs often don’t reveal everything. Testing against independent USP standards helps you verify quality and avoid risks that might otherwise go unnoticed.

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How is this different from what I already get in a CoA?

A CoA shows what the supplier chose to test for — not always what matters most. USP standards include tests for critical impurities like DEG/EG that are often missed, helping you verify what a basic CoA might overlook.

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